News

Sanofi SA is guiding for a high single-digit percentage rise in sales this year. Significantly, it also expects adjusted operating income to slightly surpass the sales increase indicating that the company is seeing a rise in profitability. The French company issued its first quarter earnings statement on 23 April – just a week before Belén Garijo takes over as chief executive. Dr Garijo succeeds Paul Hudson. She was most recently CEO at Merck KGaA and earlier in her career was an executive at Sanofi, leading pharmaceutical operations in Europe and Canada.

The Roche Group confirmed its forecast for a mid-single digit increase in sales this year following a first quarter during which sales increased by 6% at constant exchange rates, but declined by 5% in Swiss francs following a period during with the franc rose significantly in value against the dollar and other currencies. The company expects core earnings per share, expressed at constant exchange rates, to rise by a high single digit rate. This will make way for a rise in the annual dividend. As is customary, Roche did not report earnings for the quarter.

Jeito Capital closed its second private equity fund, Jeito II, on 8 April with a call to the pharmaceutical industry to meet the challenge of the patent cliff by producing more innovative new medicines for patients. Significant new financing will be available for  companies that do this following the close of Jeito II which raised €1 billion, above expectations and about double the size of Jeito I which attracted €534 million in 2021. The new fund is expected to supply capital to 15 to 20 companies with larger amounts than in the past.

France-based Kurma Partners SA announced the final closing of a new fund on 23 April to support start-up companies, largely in Europe, which show promise of developing medicines for serious or incurable diseases. The final close of Biofund IV, at €215 million, is about a third higher than the size of Biofund III, its predecessor, and was supported by several large institutions. They include the Australian pharmaceutical company CSL Ltd, the European Investment Fund, and Bpifrance, the French national investment bank.

A small molecule inhibitor of the mutated RAS protein, a high priority cancer target, has successfully delivered a significant overall survival benefit for patients with metastatic pancreatic cancer. The results were obtained in a Phase 3 trial of the RAS inhibitor daraxonrasib and reported on 13 April. The developer is Revolution Medicines Inc, a clinical-stage US biopharmaceutical company with a portfolio of RAS-addicted cancers. These are cancers that are dependent on mutant RAS activity for their survival.

China’s regulatory authority, the National Medical Products Administration, has approved Blenrep (belantamab mafodotin), a treatment for multiple myeloma which is a relatively rare blood cancer but with a global prevalence. In China, it is now the only B-cell maturation antigen (BMCA) targeting second-line therapy for the disease. “Blenrep provides a new and needed mechanism of action in therapy,” the developer GSK Plc said in a statement on 20 April. Blenrep is an antibody-drug conjugate consisting of a humanised antibody conjugated to a cytotoxic agent via a non-cleavable linker.

Marty Makary, commissioner of the US Food and Drug Administration, has invited developers of testosterone replacement therapies for men to approach the agency to discuss a possible augmentation for their products. Specifically, this means pursuing a potential new indication for low libido in men with idiopathic hypogonadism, or sexual disfunction without a known cause. “New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” he said in a statement issued on 16 April.

A new observational study led by researchers at University College London suggests that changes in the gut microbiome may provide an early indication of Parkinson’s disease risk, potentially years before clinical symptoms appear. Published in Nature Medicine on 20 April, the peer-reviewed study analysed microbial patterns in the digestive systems of individuals with Parkinson’s disease, those genetically predisposed to the condition, and healthy controls.

A veterinary vaccine using RNA technology and originally developed by Merck & Co has received a positive opinion from the European Medicines Agency on the basis of multiple, positive studies in cats. The vaccine, Nobivac NXT HCPChFeLV, contains live attenuated strains of five feline viruses, one of which is a strain of the feline leukaemia virus. This virus strain suppresses the immune system and is a common cause of cancer in cats. It is species specific and does not affect humans.

A small peptide drug in development at Oculis Holding AG of Switzerland has received regulatory designations from agencies in both Europe and the US for its promise as a treatment for optic neuritis, a disease that can seriously impair vision. Called privosegtor, the candidate drug activates pathways in the brain in order to promote the survival of neurons after an inflammatory attack. Optic neuritis can be caused by autoimmune diseases such as multiple sclerosis, or viral infections such as mumps, measles or the flu, according to the American Academy of Ophthalmology.